MAUDE Adverse Event Report: RESPIRONICS, INC. GENERATOR, OXYGEN, PORTABLE; SIMPLYGO

Model Number	1069058
Medical Device Problem Codes	Failure to Charge (1085); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Dyspnea (1816); Hypoxia (1918)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was contacted in references to a malfunction of a simplygo oxygen concentrator.The manufacturer received information stating the device is not charging and the unit is turning off during use.The patient stated the device will only work for 2 hours at a time and there are no error messages on the device while in use.The patient alleges breathing issues and low oxygen.The patient also stated he was hospitalized for the breathing issues and low oxygen and was placed on 4 liters of oxygen and was given medication for his heart and lungs.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.

• Brand Name: GENERATOR, OXYGEN, PORTABLE
• Common Device Name: SIMPLYGO
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18842994
• Report Number: 2518422-2024-11997
• Device Sequence Number: 8333316
• Product Code: CAW
• UDI-Device Identifier: 00606959020801
• UDI-Public: 00606959020801
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male